Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer
Both
Esophageal Cancer
Trial Information
Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy
Inclusion Criteria:
- 18 years of age and older
- Willing and able to provide informed consent
- Willing to comply with follow-up requirements
- Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid
or distal esophagus (clinical stage 3 or less)
- Indicated for chemotherapy and/or radiation therapy
- Ability to dilate stricture to 15mm diameter at extent of disease evaluation
- Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent
Exclusion Criteria:
- Patients contraindicated for endoscopy
- Patients with prior esophageal stent placements
- Advance stage of disease, greater than T3 tumor or M1 disease
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation
Outcome Time Frame:
8 - 10 weeks
Safety Issue:
No
Principal Investigator
Robert Martin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Louisville
Authority:
United States: Institutional Review Board
Study ID:
08-0132
NCT ID:
NCT00727376
Start Date:
March 2008
Completion Date:
February 2011
Related Keywords:
- Esophageal Cancer
- esophageal
- stenting
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| University of Louisville | Louisville, Kentucky 40202 |
